DDRFORMULA AND DDRFORMULA PLUS— 510(k) K052943
Substantially EquivalentSwissray Medical AG
FDA 510(k) clearance K052943 for DDRFORMULA AND DDRFORMULA PLUS, Substantially Equivalent on 2005-12-15. Applicant: Swissray Medical AG. Device class: 2.
Clearance details
- Applicant
- Swissray Medical AG
- Product code
- Code KPR
- Device class
- Class 2
- Regulation
- 21 CFR 892.1680
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Elizabeth, NJ, US
Recent devices under product code KPR
view allMore clearances from Swissray Medical AG
view allAdverse events under product code KPR
product code KPR- Other
- 6
- Total
- 6
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recalls naming K052943
K-number listed on FDA's recall record- Z-3191-2018 — ddR Formula B X-ray System, Model ddR Formula B X-ray system used for imaging
- Z-3248-2018 — ddR Formula B X-ray System, ddR Formula B Product Usage: X-ray system used for imaging
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K052943.
Data sourced from openFDA. This site is unofficial and independent of the FDA.